NCT01616108

Brief Summary

This study seeks to determine if bupivacaine injection of eye muscles can make them stronger and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a condition generally termed strabismus. It seeks further to find out the different effects of various concentrations or formulations of bupivacaine, and whether addition of Botox to other eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

7.4 years

First QC Date

June 7, 2012

Last Update Submit

September 19, 2019

Conditions

StrabismusEsotropiaExotropiaGraves DiseasePtosis, Eyelid

Keywords

strabismusdiplopia

Outcome Measures

Primary Outcomes (1)

  • Eye alignment

    Alignment of the two eyes as measured by prism cover test or other applicable test

    6 months after injection

Secondary Outcomes (1)

  • Percentage correction of the pre-treatment eye deviation

    6 months after injection treatment

Study Arms (1)

Bupivacaine Injection

EXPERIMENTAL

Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.

Also known as: Marcaine
Bupivacaine Injection

Eligibility Criteria

Age8 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical pattern of strabismus of 5 prism diopters or more

You may not qualify if:

  • Active eye infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strabismus Research Foundation

San Francisco, California, 94109, United States

RECRUITING

Related Publications (5)

  • Miller JM, Scott AB, Danh KK, Strasser D, Sane M. Bupivacaine injection remodels extraocular muscles and corrects comitant strabismus. Ophthalmology. 2013 Dec;120(12):2733-2740. doi: 10.1016/j.ophtha.2013.06.003. Epub 2013 Aug 2.

    PMID: 23916485BACKGROUND

  • Scott AB, Miller JM, Shieh KR. Bupivacaine injection of the lateral rectus muscle to treat esotropia. J AAPOS. 2009 Apr;13(2):119-22. doi: 10.1016/j.jaapos.2008.10.016.

    PMID: 19393509BACKGROUND

  • Scott AB, Alexander DE, Miller JM. Bupivacaine injection of eye muscles to treat strabismus. Br J Ophthalmol. 2007 Feb;91(2):146-8. doi: 10.1136/bjo.2006.110619. Epub 2006 Nov 29.

    PMID: 17135337BACKGROUND

  • Debert I, Miller JM, Danh KK, Scott AB. Pharmacologic injection treatment of comitant strabismus. J AAPOS. 2016 Apr;20(2):106-111.e2. doi: 10.1016/j.jaapos.2015.11.011.

    PMID: 27079589BACKGROUND

  • Scott AB, Miller JM, Shieh KR. Treating strabismus by injecting the agonist muscle with bupivacaine and the antagonist with botulinum toxin. Trans Am Ophthalmol Soc. 2009 Dec;107:104-9.

    PMID: 20126486RESULT

Related Links

MeSH Terms

Conditions

StrabismusEsotropiaExotropiaGraves DiseaseBlepharoptosisDiplopia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesExophthalmosOrbital DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesEyelid DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Alan B Scott, MD

    Strabismus Research Foundation

    PRINCIPAL INVESTIGATOR

  • Joel M Miller, PhD

    Strabismus Research Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan B Scott, MD

CONTACT

415 923 3120abs@srfsf.org

Joel M Miller, PhD

CONTACT

415 672 0473jmm@eidactics.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)